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The patient images are AI generated and are not real patients treated with PALFORZIA.
Individual results will vary with each patient.
POSEIDON
POSEIDON
POSEIDON
Occurred at 14 sites in
North America and 9 sites
in Europe1
Study duration:
approximately 12 months
with food challenges at
entry and exit1
146 participants
aged 1–3 years1
98 participants
received
PALFORZIA1*
48 participants
received placebo1*
*15 subjects in the PALFORZIA arm and 3 subjects in the placebo arm did not have an exit DBPCFC. Subjects without an exit DBPCFC were counted as non-responders. Secondary endpoint was met if the Farrington-Manning test for a nonzero treatment difference was significant at the two-sided 0.05 level. The primary endpoint was considered met if the lower bound of the Farrington-Manning 95% CI was greater than the prespecified margin of 15 percentage points.
In-office visit with gradually increasing peanut protein dose levels ranging from >3 mg to <300 mg.2
In-office visit with dose escalation increase ranging from 0.5 mg to 3 mg of PALFORZIA or placebo with confirmation of tolerability of the 1 mg dose on day 2.2
Participants continued onto Up-Dosing for maximum of 40 weeks starting with the 1 mg dose until 300 mg was reached. Up-Dosing was executed with an in-office dose toleration confirmed and continued with daily home dosing for ~2 weeks at each Up-Dose level. Duration of the Up-Dosing period varied for each participant depending on doses tolerated.2
Daily 300 mg dose of PALFORZIA or placebo taken at home.2
Primary endpoint and other study endpoints assessed; in-office visit to assess desensitization; peanut protein levels ranging from 3 mg to 1,000 mg.2
Data from all sites (North America and Europe) were pooled to form a single trial population. The primary efficacy endpoint being the proportion of participants who tolerated a 600 mg single dose of peanut protein with no more than mild allergy symptoms during the exit DBPCFC (desensitization).2
Secondary endpoints included the proportion of participants who tolerated 300 mg or 1,000 mg single doses of peanut protein with no more than mild symptoms and the maximum severity of symptoms during the exit DBPCFC.2
Additional exploratory, prespecified endpoints included the proportion of participants who tolerated a 2,000 mg single dose of peanut protein (Supplementary Protocol).2
†The primary efficacy endpoint was defined under guidance from each region’s major health authority.
Primary and secondary endpoints: Percentage of subjects tolerating peanut protein in the exit DBPCFC with no more than mild allergic symptoms after 6 months Maintenance.1,2
1,000 mg dose is eight times the median amount of peanut protein that
triggered an accidental allergic reaction (125 mg) in the observational
MIRABEL study.3 This median amount was studied outside of the PALFORZIA
clinical trials.
The Maintenance dose during the
study was 300 mg daily.2 Many participants who received PALFORZIA
were able to tolerate more than
300 mg of peanut protein in the exit
DBPCFC.1
Peanut allergen sensitization progressively increased in ages 1 to <3 with placebo versus PALFORZIA.4
The graphs below show the peanut allergen sensitivity levels for both PALFORZIA-treated and placebo-treated participants in the POSEIDON clinical trial (ages 1 to <3 years) as measured by their starting and ending peanut sIgE levels.*
*The data shown is an exploratory analysis of the 1 year POSEIDON clinical trial. PALFORZIA has not been studied in toddlers (1–3 years) beyond 1 year and is indicated for the mitigation of allergic reactions, including anaphylaxis that may occur with accidental exposure to peanut. The long-term variation of peanut sIgE levels in toddler patients has not been studied with PALFORZIA.1,4
In 98 toddlers, ages 1–3 years, treated with PALFORZIA, at 1 year:4
~8 in 10
(79.6%) increased
tolerability to
vs. ~1 in 5 (22.9%)
receiving placebo
More than 7 in 10
(75.3%) increased
tolerability to
vs. ~1 in 20 (6.3%)
receiving placebo
~7 in 10
(68.4%) increased
tolerability to
vs. ~1 in 25 (4.2%)
receiving placebo
6 in 10
(61.2%) increased
tolerability to
vs. ~1 in 50 (2.1%)
receiving placebo
At exploratory efficacy endpoint of 2,000 mg of peanut protein, (shown above), is the percentage of participants who experienced no more than mild symptoms at exit DBPCFC.
Starting PALFORZIA in younger patients may help improve protection against allergic reactions, including anaphylaxis.1,2
†One peanut kernel is equivalent to 300 mg.5
Peanuts shown are for illustrative purposes only.
In PALFORZIA safety data, anaphylactic reaction includes systemic allergic reactions of any severity.
In the POSEIDON study, anaphylactic reaction was reported in 8 (8.2%) PALFORZIA-treated subjects (in no subjects during Initial Dose Escalation, 2 subjects during Up-Dosing, and 6 subjects during Maintenance) and 4 (8.3%) placebo-treated subjects (in no subjects during Initial Dose Escalation, 2 subjects during Up-Dosing, and 2 subjects during Maintenance). Of the 9 anaphylactic reactions reported, in 8 children receiving PALFORZIA, only 3 were attributed to PALFORZIA, all occurring during the Up-Dosing phase. The remaining 6 reactions were due to exposure to other food allergens.1
*Anaphylactic reactions were graded as Mild (skin and subcutaneous issues, gastrointestinal and/or mild respiratory), Moderate (mild symptoms + features suggesting moderate respiratory, cardiovascular, or gastrointestinal symptoms), or Severe (hypoxia, hypotension, or neurological compromise).6
†Most anaphylactic reactions were related to non-peanut food allergen exposure. Anaphylactic reactions by events: 13 anaphylactic reaction events (9 PALFORZIA, 4 placebo); 10 related to other food allergen exposure (6 PALFORZIA, 4 placebo); none related to accidental peanut exposure.1,2
‡Total percentage does not equal the sum of Mild and Moderate reactions because 1 subject experienced 2 related anaphylactic reactions (1 Mild and 1 Moderate).6
§PALFORZIA: 3 subjects with viral infections, 2 subjects with asthma, 1 subject with viral infection and asthma; placebo: 1 subject with asthma, 1 subject with carbon monoxide poisoning.6
¶No eosinophilic esophagitis.6
Treatment-emergent adverse reactions are included in the table if they occurred in ≥5% of PALFORZIA-treated subjects across all dosing phases combined. Data across all dosing phases combined are not shown.
At each level of summarization (any event, system organ class, and preferred term), subjects with more than one adverse reaction were counted only once within study period.
[1] Adverse reactions were coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 21.1. [2] Includes preferred terms of rhinorrhea, rhinitis, and rhinitis allergic. [3] Includes preferred terms of wheezing and stridor. [4] Includes preferred term of abdominal pain, abdominal pain upper, and abdominal discomfort. [5] Includes preferred terms of vomiting and regurgitation. [6] Includes preferred terms of diarrhea and frequent bowel movements. [7] Includes preferred terms of oral pruritus, tongue pruritis, and lip pruritus. [8] Includes preferred terms of oropharyngeal pain, oral discomfort, odynophagia, and oral pain. [9] Includes preferred terms of urticaria and urticaria papular. [10] Includes preferred terms of rash, rash erythematous, rash generalized, rash macular, rash papular, rash pruritic, eczema, erythema, and papule. [11] Includes preferred terms of pruritus, pruritus generalized, ear pruritus, eye pruritus, and nasal pruritus.
A total of 15 (15.3%) PALFORZIA-treated subjects and 3 (6.3%) placebo-treated subjects discontinued for any reason in the POSEIDON study. Adverse reactions led to study discontinuation in 5.1% of PALFORZIA-treated subjects and no placebo-treated subjects during Up-Dosing in the POSEIDON study, and 2.3% PALFORZIA-treated subjects and no placebo-treated subjects during Maintenance dosing.1
Gastrointestinal reactions were the most common reason leading to discontinuation of study product during Up-Dosing (3.1% PALFORZIA, none in placebo), followed by respiratory disorders (3.1% PALFORZIA, none in placebo) in the POSEIDON study. No PALFORIZA-treated subjects discontinued during Initial Dose Escalation.1
#At each level of summarization (any event, system organ class, or preferred term), participants with more than one AE related to trial product were counted only once within each trial period. Values in bold indicate AEs with 5 higher incidence in the PALFORZIA group than in the placebo group.
∆There were ≥20% of participants in either treatment group with a ≥5% higher incidence in the PALFORZIA group.
**Systemic allergic reactions were defined as anaphylactic reaction of any severity.
The maximum severity of symptoms at any exit challenge dose was predominately none to mild for PALFORZIA-treated participants and mild to moderate for placebo-treated participants.2
No participant had symptoms considered life threatening or fatal.2
Models for illustrative purposes only.
Models for illustrative purposes only.
AE, adverse event; CI, confidence interval; DBPCFC, double-blind placebo-controlled food challenge; GI, gastrointestinal; IDE, Initial Dose Escalation; IQR, interquartile range; LS, least square; psIGE, peanut-specific immunoglobulin E; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.
References:
WARNING: ANAPHYLAXIS
INDICATION
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.
PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 years of age and older.
PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.
WARNINGS AND PRECAUTIONS
ANAPHYLAXIS
PALFORZIA can cause anaphylaxis, which may be life-threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.
Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.
Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.
All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered under observation in a certified health care setting.
Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.
ASTHMA
Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.
PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.
EOSINOPHILIC GASTROINTESTINAL DISEASE
Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.
GASTROINTESTINAL ADVERSE REACTIONS
Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.
ADVERSE REACTIONS
The most common adverse reactions reported in subjects ages 1 through 3 years treated with PALFORZIA (incidence ≥5%) are cough, sneezing, rhinitis, nasal congestion, throat irritation, wheezing, abdominal pain, vomiting, diarrhea, oral pruritus, oropharyngeal pain, urticaria, rash, pruritus, and perioral dermatitis.
The most common adverse events reported in subjects ages 4 through 17 years treated with PALFORZIA (incidence ≥ 5% and at least 5% greater than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.